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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA: US Clinical Research Using Three-Parent Baby Technique is Illegal

The US Food and Drug Administration (FDA) said Friday that it is illegal to perform research in the US on a new type of technology that showed promise last year in helping a woman who had multiple miscarriages because of a genetic disorder to give birth to a baby boy in Mexico without that disorder.

The technology, known as mitochondrial replacement technology (MRT), deals with mitochondrial DNA passed down only from mother to child. In September 2016, MRT was used to help a mother who carries genes for the fatal Leigh syndrome and had multiple miscarriages to give birth.

According to the New Scientist, Dr. John Zhang of the New York-based New Hope Fertility Center and his team removed the nucleus from one of the mother’s eggs and inserted it into a donor egg that had had its own nucleus removed. The resulting egg included nuclear DNA from the mother and mitochondrial DNA from a donor and was then fertilized with the father’s sperm.

Prior to the boy's birth, the Institute of Medicine (IOM) of the National Academies of Sciences Engineering, and Medicine issued a report detailing how it believes FDA should regulate MRT trials.

FDA, however, made clear on Friday that although the use of MRT is a possible treatment for mitochondrial disorders, the technique also "introduces a genetic modification and raises safety concerns."

Since December 2015, Congress has said in its annual federal appropriations laws that FDA is prohibited from accepting applications for clinical research using MRT.

"Therefore, clinical research using MRT in humans cannot legally proceed in the United States," FDA said in an advisory on legal restrictions on the use of MRT to introduce donor mitochondria into reproductive cells intended for transfer into a human recipient.

FDA Untitled Letter for Zhang

In addition to the advisory on legal restrictions, FDA sent an untitled letter to Zhang saying he continues to market MRT to prevent the transmission of mitochondrial disease and to treat infertility even after FDA declined a pre-investigational new drug (IND) meeting for a clinical investigation.

The agency notes that Zhang’s use of MRT is subject to regulations on human cells, tissues, or cellular or tissue based products (HCT/Ps) under 21 CFR Part 1271, issued under authority of section 361 of the Public Health Service Act.

"The MRT-produced HCT/P is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Moreover, as noted above, FDA cannot accept an IND for a clinical investigation involving your HCT/P, and such human subject research cannot legally be performed in the United States. Nor is exportation permitted unless it meets the requirements of an applicable export exemption," the letter said.

The New Hope Fertility Center did not respond to a request for comment.